Identity
- Trade Name
- Autoimmune EIA FDA UDI
- Generic Name
- Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD, kit enzyme immunoassay (EIA) FDA UDI
- Device Name
- Autoimmune EIA Anti-Saccharomyces Cerevisiae Antibodies (ASCA) IgA FDA UDI
- Model / Reference
- 425-2320 FDA UDI
- Description
- Autoimmune EIA Anti-Saccharomyces Cerevisiae Antibodies (ASCA) IgA FDA UDI
Identifiers
- Catalog Number
- 4252320 FDA UDI
- Primary DI / UDI-DI
- 00847817018534 FDA UDI
- 510(k) Number
- K051492 FDA UDI
- FDA Product Code
- NBT FDA UDI
- GMDN Term
- Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD, kit enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5785 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD, kit enzyme immunoassay (EIA)
Autoimmune EIA by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD, kit enzyme immunoassay (EIA).
- AESKULISA® ASCA-A — Aesku.Diagnostics GmbH & Co. KG · Class II
- AESKULISA® ASCA-A — Aesku.Diagnostics GmbH & Co. KG · Class II
- AESKULISA® ASCA-A — Aesku.Diagnostics GmbH & Co. KG · Class II
Cleared under the same submission
K051492 also covers:
- AESKULISA® ASCA-A — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ASCA-A — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ASCA-A — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ASCA-G — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ASCA-G — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ASCA-G — Aesku.Diagnostics GmbH & Co. KG
- Autoimmune EIA — Bio-Rad Laboratories
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI e15618d9-da48-48c2-a1a5-fa2e12f79ea4 38 fields · synced Jun 7, 2026